MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. BD ALARIS SMARTSITE EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	20039E
Medical Device Problem Codes	Complete Blockage (1094); Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date of event is unknown; bd awareness date used.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd alaris smartsite extension set had flow issues.The following information was provided by the initial reporter: the control clamp is not tight enough to vent air.
Additional Manufacturer Narrative
Investigation result: sixteen 20039e samples were received for investigation; one sample was received without packaging, the remaining samples were received in opened packaging, three from lot 24036013, two from lot 24066976, and ten from lot 25035358.The customer reported that "the control clamp is not tight enough to vent air" for the returned lots as well as 24125109 (likely the sample without packaging).The returned samples were subjected to functional testing by priming and flushing using a 50ml bd plastipak syringe and the following was observed within the returned lots: the sample received without packaging was occluded.The samples from lot 24036013 all flushed without any restriction of flow.The samples from lot 24066976 had one occluded, and one flushed without any issues.The samples from lot 25035358 had one occluded, and nine flushed without any issues.In all instances where the sample was occluded, no fluid flow was observed beyond the smartsite.The details of this feedback were forwarded to the manufacturing site for investigation.Following a small number of similar reports, bd has conducted an in-depth investigation to identify any potential contributing factors for occlusion at the smartsite of this nature.The investigation has determined that a potential contributor could be the result of an insufficient amount of fluorosilicone having been injected into the piston of the smartsite during the assembly process; fluorosilicone is used as a lubricant within the smartsite to ensure the consistent opening of the piston when the smartsite is activated, and an insufficient amount may cause a temporary occlusion.They confirmed that the incorrect amount of fluorosilicone was likely due to a fault within the assembly machine during manufacture of the affected smartsite.A review of the production records for lot 24036013, 24066976, 24125109, and 25035358 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Since the manufacture of the reported lot, the automatic assembly machine has been repaired to ensure the fluorosilicone is being correctly dispensed into each smartsite; furthermore at the start of the assembly process the manufacturing operative will continue to measure whether a sufficient amount of fluorosilicone is being injected.The quality team at the manufacturing site has been informed of this report and will continue to monitor the incoming feedback and remain vigilant to issues of this nature during future production.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the smartsite products in the past 12 months.
Event or Problem Description
No additional information.

• Brand Name: BD ALARIS SMARTSITE EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23497738
• Report Number: 9616066-2025-03394
• Device Sequence Number: 13003199
• Product Code: FPA
• UDI-Device Identifier: 07613203011952
• UDI-Public: (01)07613203011952
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K061285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 20039E
• Device Lot Number: 24036013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown